Patients with a primary invasive melanoma are recommended to undergo excision of the primary lesion with a wide margin. There is evidence that less radical margins of excision may be just as safe. This is a randomised controlled trial of 1 cm versus 2 cm margin of excision of the primary lesion for adult patients with stage II primary invasive cutaneous melanomas (AJCC 8th edition) to determine differences in disease-free survival. A reduction in margins is expected to improve patient quality of life.
This study will determine whether there is a difference in disease-free survival rates for patients with primary cutaneous melanoma with Breslow thickness \> 2mm or 1-2mm with ulceration (pT2b-pT4b, AJCC 8th edition), treated with either a 1cm excision margin or 2cm margin. The study is designed to be able to prove or disprove that there is no difference in risk of the tumour recurring around the scar or anywhere else in the body between the two groups of patients. If the study shows no risk of tumour recurrence then we will also be able to determine how much of an impact the narrower excision has on patients in terms of improved quality of life and reduced side effects from the surgery and melanoma disease. This trial will also evaluate and determine the economic impact of narrower excision margins on the health services and society in general.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2,998
A wide local excision involves removing an extra "safety margin" of skin surrounding the original melanoma site, to ensure that any remaining scattered melanoma tumour cells that may have been left behind after the first initial biopsy/surgery are removed.
A wide local excision involves removing an extra "safety margin" of skin surrounding the original melanoma site, to ensure that any remaining scattered melanoma tumour cells that may have been left behind after the first initial biopsy/surgery are removed.
University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, United States
RECRUITINGBanner MD Anderson Cancer Center
Gilbert, Arizona, United States
RECRUITINGMayo Clinic Phoenix
Phoenix, Arizona, United States
RECRUITINGUniversity of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Disease-Free Survival
Time from randomisation until the first clinically, histologically or radiologically confirmed recurrence of melanoma at any body site, or death from any cause.
Time frame: 0-60 months
Local Recurrence
Time from randomisation to any clinically, histologically or radiologically confirmed LR of melanoma including satellite lesions and in transit metastases between the primary site and the regional draining lymph nodes or death from any cause.
Time frame: Day 0-Trial Completion (max. 120 months)
Distant Disease-Free Survival
Time from randomisation to any clinically, histologically or radiologically confirmed distant recurrence of melanoma or death from any cause
Time frame: Day 0-Trial Completion (max. 120 months)
Melanoma-Specific Survival
Time from randomisation to death due to melanoma
Time frame: Day 0-Trial Completion (max. 120 months)
Overall Survival
Time from randomisation to death from any cause
Time frame: Day 0-Trial Completion (max. 120 months)
Melanoma-specific Quality of Life: FACT-M questionnaire
Measured by FACT-M (Functional Assessment of Cancer Therapy - Melanoma) questionnaire - It consists of two subsections: The FACT-G subsection is a 27-item compilation of general questions divided into four primary QOL domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. It is considered appropriate for use with patients with any form of cancer. The Melanoma Surgery Subscale evaluates melanoma-specific symptoms such as surgical morbidity and side effects.
Time frame: Baseline, 3, 6, 12 & 24 months
Neuropathic Pain: PainDetect questionnaire
Measured by PainDetect questionnaire
Time frame: Baseline, 3, 6, 12 & 24 months
Health-related Quality of Life: EQ-5D-5L questionnaire
Measured by EuroQoL EQ-5D-5L questionnaire - This tool contains 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
Time frame: Baseline, 3, 6, 12 & 24 months
Surgery Related Adverse Events
The following surgical-related adverse events will be recorded from the time of surgery to 12-months following surgery (inclusive): * wound dehiscence * seroma/haematoma * haemorrhage * infection * skin graft failure * necrosis of flap used for reconstruction * deep venous thrombosis * urinary tract infection * pneumonia * cardiac complications * lymphoedema
Time frame: Up to 12-months from the date of surgery
Health Economic Evaluation
Data collected for economic analysis will be from hospital notes, MBS and PBS data (Australia) and patient reported outcome measures (including an employment questionnaire) at baseline, 3, 6, 12 and 24 months and at melanoma recurrence.
Time frame: Baseline, 3, 6, 12 & 24 months
Serious Adverse Events
All Serious Adverse events (SAEs), will be recorded from randomisation until 12 months post the surgical intervention or until the patient withdraws or dies.
Time frame: from randomisation up to 12-months post-surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, United States
RECRUITINGLos Angeles General Medical Center
Los Angeles, California, United States
RECRUITINGLos Angeles General Medical Center
Los Angeles, California, United States
RECRUITINGUSC Norris Comprehensive Cancer Center
Los Angeles, California, United States
RECRUITINGUSC Norris Comprehensive Cancer Center
Los Angeles, California, United States
RECRUITINGThe Angeles (Cedars-Sinai Medical Center and its Affiliates)
Los Angeles, California, United States
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